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Integrative Medicine of IgA Nephropathy | Clinical Trials | Clareo Health

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Integrative Medicine of IgA Nephropathy

Treatment of Shentong Granules Plus Prednisone on Patients With Severe IgA Nephropathy(Ying-deficiency of the Liver and Kidney Pattern): a Randomized, Double-blind,Placebo-controlled Multicentre Clinical Trial

NCT02712697•Shanghai University of Traditional Chinese Medicine

View on ClinicalTrials.gov

Summary

Detailed Description

The present study was designed to identify the efficacy and safety of Integrative Medicine by joint oral steroid medicine on liver-kidney yin deficiency, severe IgA nephropathy. Furthermore, search for potential diagnostic predictor in IgA Nephropathy by Proteomics and Metabolomics. Combined with TCM Syndrome research, the investigators will clarify targets or mechanisms of herbal treatment. Eventually, to form a more clinically appropriate standardized combination treatment of severe IgA nephropathy.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. The primary IgAN was confirmed by renal biopsy and clinical examination, and the pathological manifestations were Lee's grade and above;
•2. TCM is liver kidney yin deficiency syndrome;
•3. age 18-70 years old, sex, nationality is not limited;
•4. CKD phase 2-4 （89 ml/min\>eGFR（EPI Formula）\>15ml/min/1.73m2）;
•5. 24 hour urinary protein≥1g.

Exclusion Criteria

•1. It had received immunosuppressive drugs and cytotoxic therapy within the past 3 months more than 4 weeks;
•2. It had received corticosteroids (prednisone or prednisolone) within the past 3 months more than 20mg/d for more than up to 4 weeks;
•3. Acute or progressive glomerulonephritis patients;
•4. Severe complications threat to life, such as severe infection;
•5. Active hepatitis B and liver function test sustained abnormal;
•6. Patients with malignant tumor or have a history of cancer, HIV infection, history of mental illness, acute central nervous system diseases, severe gastrointestinal diseases, prohibition of the use of hormone;
•7. Abnormal glucose metabolism, fasting blood glucose over 6.2mmol/L;
•8. Gravid or lactation woman;
•9. Other clinical trials are being studied;
•10. Merger with other serious disease and dysfunction of the organ.

Locations (1)

Department of Nephrology,Longhua Hospital

Shanghai, China

Key Dates

Start Date

June 1, 2016

Primary Completion Date

December 1, 2017

Completion Date

December 1, 2017

Last Updated

March 18, 2016

Enrollment

140

ESTIMATED participants

Conditions

Primary IgA Nephropathy

Interventions

WM (Shentong Granules)

DRUG

Hormone (prednisone)

DRUG

Contacts

Yueyi Deng, MD.

CONTACT

+86-021-64385700-3226 dengyueyi@medmail.com.cn

Wanjia Chen, MS.

CONTACT

+86-021-64385700-3222 wdgzkj@sina.com

A Study to Evaluate the Efficacy and Safety of Sefaxersen (RO7434656) in Participants With Primary Immunoglobulin A (IgA) Nephropathy at High Risk of Progression

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NOT_YET_RECRUITINGPHASE2

Evaluate the Efficacy and Safety of NTQ5082 Capsules in Patients With Primary IgA Nephropathy

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COMPLETEDPHASE3

Efficacy and Safety of Nefecon in Patients With Primary IgA (Immunoglobulin A) Nephropathy

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 18, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Integrative Medicine of IgA Nephropathy

Inclusion Criteria

Exclusion Criteria

A Study to Evaluate the Efficacy and Safety of Sefaxersen (RO7434656) in Participants With Primary Immunoglobulin A (IgA) Nephropathy at High Risk of Progression

Evaluate the Efficacy and Safety of NTQ5082 Capsules in Patients With Primary IgA Nephropathy

Efficacy and Safety of Nefecon in Patients With Primary IgA (Immunoglobulin A) Nephropathy

A Study of RC18 Administered Subcutaneously to Subjects With Primary IgA(Immunoglobulin A) Nephropathy

Replication of the NefIgArd Trial of TRF-budesonide in Primary IgAN

Hydroxychloroquine Sulfate for Reduction of Proteinuria in Patients With IgA Nephropathy: a Self- Controlled Study